Senior CSA Validation Engineer - Remote

Two River Consulting Partners; Elm (PA); Remote; USD 120,000 - 170,000; Full time

Job summary

Two River Consulting Partners seeks an experienced CSA Consultant/Senior Validation Engineer to drive GxP compliance across PV, Clinical, and Regulatory Affairs systems. You will partner with Quality, IT, and business stakeholders to ensure systems are compliant throughout their lifecycle.

You will develop and review validation deliverables, oversee readiness before testing, and support change control and documentation.

Qualifications

• 5–8 years hands-on CSA/CSV experience in Pharmacovigilance, Clinical or Regulatory Affairs.
• Strong knowledge of CSA principles, CSV, and SDLC processes.
• Experience authoring or reviewing validation documentation.
• Knowledge of FDA, EMA, ICH regulations and data integrity expectations.

Responsibilities

• Provide CSA/CSV SME support across PV, Clinical, and Regulatory Affairs platforms.
• Develop and review validation deliverables (Validation Plans, Risk Assessments, Traceability Matrices, Validation Summary Reports).
• Review lifecycle documentation (URS, specifications, test plans, test summaries) per ALCOA+ standards.
• Oversee validation readiness and ensure prerequisites are met before testing.
• Support change control, configuration management, and release activities.
• Collaborate with Quality, System Owners, and Business Process Owners to maintain compliance.
• Guide risk-based, CSA-driven validation approaches.
• Monitor regulatory inspection observations and internal audits for improvement.

Skills

CSA/CSV expertise

GxP system experience

Regulatory knowledge (FDA/EMA/ICH)

Validation documentation

Stakeholder communication

Job description

Two River Consulting Partners seeks an experienced CSA Consultant/Senior Validation Engineer to drive GxP compliance across PV, Clinical, and Regulatory Affairs systems. You will partner with Quality, IT, and business stakeholders to ensure systems are compliant throughout their lifecycle.

You will develop and review validation deliverables, oversee readiness before testing, and support change control and documentation.